Hot Flashes, Postmenopausal Flushing
Conditions
Brief summary
World health Organization (WHO) estimates that by 2030, 1.2 billion women will be over 50 years old. With a prevalence of 70%, a hot flash is the most distressing symptoms associated with menopause. Postmenopausal associated sleep disturbances could affect those women social activities and one's daily positive functioning. Therefore, some patients and their providers seek alternative treatments such as relaxation techniques, acupressure, yoga, reflexology, regular exercise, balanced nutrition, herbal supplements, appropriate clothing, and frequent showers, have been shown to be effective in reducing symptoms associated with depression. So, this study will be the first one in this issue. Therefore, it will have valuable benefits in physical therapy field and scientific research.
Detailed description
Fifty-four postmenopausal women suffering from moderate to severe hot flashes diagnosed with hot flashes questionnaire, and sleep disturbances diagnosed with Pittsburgh quality sleep index \>5. Their age ranged from 45-55 years old with their body mass index ranged from 25 to 30 kilogram per meter square. Outcome measures were Pittsburgh sleep quality index and Hot flashes questionnaire, both were conducted at baseline and after the end of the study program. after recruiting study population, they will be divided into two equal groups randomly. Group A; will received foot reflexology (medical border just above the heel, reflex points associated with adrenal, hypothalamus, pituitary glands, heart and lung via manual pressure at reflexology zone), for 15 minutes, 3 sessions per week for 6 weeks. Group B; will received acupressure ((Shenmen point, Sanyinjiao point, Fengchi point; Yintang point), for 21 minutes, 3 sessions per week for 6 weeks.
Interventions
OTHERFoot Reflexology
Foot Reflexology is an alternative medical practice involving the application of pressure to specific points on the feet. It has been reported as a non-invasive complementary therapy that was addressed as an effective technique that is reported to reduce premenstrual symptoms.
OTHERAcupressure
Acupressure is a sort of massage therapy, was addressed as an effective technique that is reported to reduce premenstrual symptoms. Acupressure is a well-known form of Traditional Chinese Medicine that is a component of alternative treatments.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Each participant will have one identification number that will be used to assign participants into two equal groups in number (n=27), sequentially numbered index cards will be secured in opaque envelopes. Another assistant for the researcher will open the sealed envelope and will allocated the participants according to their groups.
Intervention model description
A prospective, randomized, controlled trial.
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Age ranged from 45 to 55 years old. * Their body mass index ranged from 25 to 3 kilograms per meter square. * Postmenopausal women suffering from moderate to sever hot flashes assessed by Hot Flashes Questionnaire. * Postmenopausal women suffering from sleep disturbances more than five assessed by Pittsburgh sleep quality index.
Exclusion criteria
* Any emotional stress during at least 6 months. * Any pharmacological medicines lead to sleep disturbances. * Any mental disorders affect their sleep cycle. * Taking hormone replacement therapy for the past six months. * Using herbal medicine to improve menopausal symptoms severity. * Circular job in particular night shifts. * Sensorineural problems in their feet.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index | Pretreatment and immediately Posttreatment. | A reliable, validated, self-reported questionnaire for assessing sleep quality. It is available of validated Arabic form that consists of seven components, namely, subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over a 1-month time interval. It held a good internal consistency, and convergent, also divergent validity. Each component scores are derived, each scored 'zero' means no difficulty, to 'three' means sever difficulty. component scores are summed to gain the whole score range 'zero to twenty-one' Higher scores indicates worse sleep quality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hot Flashes Questionnaire | Pretreatment and immediately Posttreatment. | A valid and reliable measure for severity of hot flashes. It is an appropriately sensitive tool to negative changes over time, with its cut-points and minimally important differences could prove a useful tool in targeting important issues regarding therapeutic interventions, and monitoring management progress and response using a 0 (do not interfere) to 10 (completely interfere) point scale. A total score is computed by summing items. Higher scores indicate higher interference due to hot flashes and thus, greater impact on quality of life. |
Countries
Egypt
Contacts
Primary ContactDr Mohamed A Awad, PHD
Backup ContactElham S Hassan, PHD
Outcome results
None listed